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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065419

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NDA 065419 describes AZITHROMYCIN, which is a drug marketed by Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sagent Strides, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-five NDAs. It is available from fifty-one suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 065419

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065419

Ingredient-typeMacrolides

Medical Subject Heading (MeSH) Categories for 065419

Suppliers and Packaging for NDA: 065419

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065419 ANDA Teva Pharmaceuticals USA, Inc. 0093-7148 0093-7148-23 15 mL in 1 BOTTLE (0093-7148-23)
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065419 ANDA Teva Pharmaceuticals USA, Inc. 0093-7149 0093-7149-23 15 mL in 1 BOTTLE (0093-7149-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Jun 24, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Jun 24, 2008TE:ABRLD:No


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